Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer

Purpose: This phase III study compared docetaxel and doxorubicin in patients with metastatic breast cancer who had received previous alkylating agent-containing chemotherapy

A phase II trial with docetaxel (Taxotere) in second line treatment with chemotherapy for advanced breast cancer. A study of the EORTC Early Clinical Trials Group.

BACKGROUND: Docetaxel, a semisynthetic analog of paclitaxel, made for the needles of the European yew, Taxus baccata, is a potentially important chemotherapeutic agent for the treatment of cancer. PATIENTS AND METHODS: In a phase II study patients with advanced and/or metastatic breast cancer and bidimensionally measurable disease, were treated with docetaxel 100 mg/m2 every 3 weeks as a 1 hour infusion without any premedication. Treatment was evaluated after 2 courses and every 2 subsequent courses. RESULTS: Thirty-nine patients were entered, 32 were eligible. The eligible patients had a median age of 51 years (range 30-73) and a performance status WHO 1 median, (range 0-2). Twenty-eight patients had been treated with surgery, 24 with radiation. Hormonal treatment was previously given in 23, chemotherapy in 32. Of 24 patients treated as second line strategy, 13 achieved a partial remission, 1 a complete remission (overall response rate 58% (95% CI 37%-78%)). Eight patients treated as first line: 2 PR's, 1 CR. The median overall response duration was 38 weeks. The main toxicity consisted of transient grade 4 neutropenia in 149 of 167 evaluable courses (89%). However, the related infection rate was low. Re-treatment at 3 weeks, as scheduled, was nearly always possible. Other toxicities consisted of skin reactions (81%) and nail changes (41%), neurosensory toxicity (59%) and occasionally hypersensitivity reactions (16%). Fluid retention was a toxicity of major concern, observed in 59% of patients. CONCLUSION: Docetaxel is a very active drug against breast cancer. Further studies are required to alleviate the non-hematological toxicities.Clinical TrialClinical Trial, Phase IIJournal ArticleMulticenter StudySCOPUS: ar.jinfo:eu-repo/semantics/publishe

Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial

Irinotecan is active against colorectal cancer in patients whose disease is refractory to fluorouracil. We investigated the efficacy of these two agents combined for first-line treatment of metastatic colorectal cancer

Lenalidomide in combination with melphalan and dexamethasone in patients with newly-diagnosed AL amyloidosis: a multicenter phase 1/2 dose escalation study.

International audienceNew treatment options are required for primary systemic AL amyloidosis (AL). This phase 1 / 2 dose-escalation study aimed to determine the maximum tolerated dose (MTD) of lenalidomide in combination with melphalan and dexamethasone (M-dex), and to assess the efficacy and tolerability of this therapy for patients with de novo AL. Twenty-six patients were enrolled across 4 cohorts: M-dex plus lenalidomide 5, 10, 15 and 20 mg once daily on days 1-21 in a 28-day cycle. No DLT was observed in cohort n degrees 1, 2 and 3. Four patients / 7 in cohort n degrees 4, M-dex + lenalidomide 20 mg/day, experienced dose-limiting toxicity. 15 mg lenalidomide was defined as MTD. A complete hematologic response was achieved in 42% at the dose of 15 mg of lenalidomide / day. After a median follow-up of 19 months, estimated 2-year overall survival and event-free survival (EFS) were 80.8% and 53.8%, respectively. Hematologic and organ responses were both associated with superior EFS rates (P = .0001). A higher EFS was also observed in patients whose free light chains decreased by more than 50% during therapy (P = .019). Lenalidomide 15 mg/day plus M-dex is a new effective combination therapy in patients with newly diagnosed AL. This study is registered at http://clinicaltrials.gov as NCT00621400